Template Information
This drug manufacturer audit checklist can be used to perform systematic audits of a pharmaceutical manufacturing facility and measure compliance with gmp guidelines.
Category: health-services
Template Questions
- Organizational & Management Responsibilities
- Document Control Program
- Employee Orientation, Quality Awareness, and Job Training
- Indicate how on-going, periodic GMP training is accomplished.
- Plant Safety and Security
- Internal Quality/GMP Audit Program
- Quality Cost Program
- Facility Design and Layout
- Environmental Control Program
- Facility Maintenance and Good Housekeeping Program
- Outside Contractor Control Program
- Design and Placement
- Equipment Identification
- Equipment Maintenance & Cleaning
- Measurement Equipment Calibration Program
- Equipment Qualification Program
- Material/Component Specification and Purchasing Control
- Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
- Material Component Storage and Handling
- Inventory Control Program
- Vendor (Supplier) Control Program
- Material/Component/Label Verification, Storage, and Handling
- Equipment/Line/Area Cleaning, Preparation, and Clearance
- Operational Process Validation and Production Change Order Control
- In-Process Inspection, Sampling, and Laboratory Control
- Reprocessing/Disposition of Materials
- Finished Product Verification, Storage, and Handling
- Finished Product Inspection, Sampling, Testing, and Release for Distribution
- Distribution Controls
- Marketing Controls
- Complaint Handling and Customer Satisfaction Program
- Final Notes
- Sign off